- The acquisition includes IDRX-42, a highly selective tyrosine kinase inhibitor (TKI) designed to treat gastrointestinal stromal tumors (GIST).
- IDRX-42 offers the potential to address all major KIT mutations in GIST that drive tumor growth and progression and improve tolerability and gaps in current therapies.
- The acquisition adds to GSK's growing portfolio in the treatment of gastrointestinal (GI) cancers.
- GlaxoSmithKline pays up to $1.15 billion
PLYMOUTH, Mass.–( BUSINESS WIRE )–GSK plc (NYSE: GSK) and IDRx (IDRx) today announced they have entered into an agreement under which GSK will acquire… IDRx, a Boston-based company, is a clinical-stage biopharmaceutical company dedicated to developing precision therapies to treat GIST. Under the agreement, GSK will pay US$1 billion upfront, with the possibility of an additional payment of US$150 million upon successful regulatory approval. The acquisition includes the lead molecule, IDRX-42, a highly selective KIT TKI being developed as a first- and second-line therapy for the treatment of GIST.
GIST typically appears in the gastrointestinal tract with 80% of cases driven by mutations in the KIT gene that lead to the growth, spread, and survival of cancer cells (primary or activating mutations). 1 90% of patients treated in first-line develop new KIT mutations (secondary or resistant mutations) that typically lead to relapse with limited treatment options.2 Currently, there are no approved TKIs that prevent the full spectrum of clinically relevant primary and secondary mutations in KIT.
IDRX-42 has shown activity against all major primary and secondary KIT mutations and is designed to improve outcomes for patients with GIST. This broad range of mutational coverage, combined with high selectivity that can improve tolerability, offers the potential for a best-in-class profile.
Luke Miles, Chief Commercial Officer of GSK, said: IDRX-42 complements our growing portfolio of gastrointestinal cancers. This acquisition is consistent with our approach of acquiring assets that meet validated objectives and where there are clear unmet medical needs, despite existing approved products.
Tony Wood, GSK's Chief Scientific Officer, said: We are excited about the early data from IDRX-42 and its unique ability to target all clinically relevant KIT mutations found in GIST, a significant gap in the current standard of care. We look forward to accelerating its development in 2025 to redefine treatment.
Updated clinical data from StrateGIST 1, an ongoing Phase I/Ib trial of IDRX-42 in patients with advanced GIST, were presented in an oral presentation at the 2024 Annual Meeting of the Connective Tissue Oncology Society (CTOS). These data demonstrate promising antitumor activity of IDRX-42 in patients with advanced GIST with a manageable safety profile. Across patients with second-line or larger GIST, and among all KIT mutation subgroups, the objective response rate (ORR) by adjusted RECIST v1.1 in the overall evaluable efficacy population was 29% (n = 87), including response One complete (CR) and 24 partial responses (PRs). Among patients who had received 1 prior line of treatment, the ORR was 53% (n = 15) including 1 CR and 7 PRs.3
Of all patients, two primary recipients were awaiting confirmation at the time of data cutoff, and both were subsequently confirmed. Robustness data emerging from StrateGIST 1 was also favorable. IDRX-42 was generally well tolerated and treatment-related adverse events (TRAEs) were mainly low-grade at the recommended phase Ib dose.4
Tim Claxon, CEO of IDRx, said: We look forward to working with GSK to develop IDRX-42 for patients with GIST as there have not been significant advances in the standard of care in nearly 20 years. Combining our experience to date with GSK's expertise in gastrointestinal cancers, global clinical development capability, and strong commercial presence in oncology will help accelerate the development of this new medicine for patients.
GSK has a growing portfolio of development targeting significant clinical needs in gastrointestinal cancers, including ongoing trials with dostarlimab and GSK5764227 (GSK'227), an antibody combination targeting B7-H3. This agreement reflects GSK's approach to identifying potentially best-in-class molecules with targeted mechanisms of action. This deal supports GlaxoSmithKline's growth ambitions until 2031 and beyond.
IDRx was founded in 2021 with the goal of addressing the limitations of today's precision cancer medicines with powerful, highly selective targeted therapies to halt key tumor escape mechanisms and prolong patients' response to treatment. IDRx investors include Andreessen Horowitz (a16z), Casdin Capital, Nextech Invest, Forge Life Science Partners, RA Capital Management, Commodore Capital, Blackstone (NYSE:) Multi-Asset Investing, and Rock Springs Capital. IDRx founders include George Dimitri, MD, FACP, FASCO, FAACR, Nicholas Lydon, PhD, Alexis Buresi, Robert Forrester and Ben Auspitz.
Financial considerations
Under the terms of the agreement, GSK will acquire one hundred percent (100%) of the outstanding equity (including all options and other incentive equity) in IDRx for up to $1.15 billion in aggregate cash consideration, including an upfront payment. It is worth 1 billion US dollars. With the potential for an additional payment of US$150 million based on successful regulatory approval. GSK will also be responsible for success-based milestone payments as well as tiered royalties for IDRX-42 owed to GSK. Merck (NS:) KGaA, Darmstadt, Germany.
This transaction is subject to customary conditions, including clearances by applicable regulatory agencies under the Hart-Scott-Rodino Act in the United States.
For IDRx, Centerview Partners LLC is acting as exclusive financial advisor and Goodwin Procter LLP is serving as legal advisor. For GSK, Leerink Partners LLC is acting as exclusive financial advisor.
About Guest
Gastrointestinal stromal tumors (GIST) are the most common subtype of soft tissue sarcoma, with approximately 80,000 to 120,000 patients diagnosed with GIST annually worldwide.5 GIST typically appears in the gastrointestinal tract with 80% of cases driven by mutations in the KIT gene. Which leads to the growth, spread and survival of cancer cells (primary or activating mutations in exons 9 and 11).6 In addition, about 90% of patients treated in first-line develop new KIT mutations (secondary or resistant mutations in exons 13 and 17) that typically lead to relapse with limited treatment options.7 There are no approved TKIs that prevent the full spectrum of clinically relevant primary and secondary mutations. In KIT.
About IDRX-42
IDRX-42 is a highly selective, investigational small molecule tyrosine kinase inhibitor (TKI) designed to target all major KIT mutations in GIST. The US Food and Drug Administration (FDA) has granted Fast Track designation to IDRX-42 for the treatment of patients with GIST after disease progression or intolerance to imatinib, and orphan drug designations for the treatment of GIST.
About IDRx
IDRx is a clinical-stage biopharmaceutical company dedicated to transforming cancer care through intelligently designed precision therapies. IDRx aims to address the limitations of today's precision cancer medicines with powerful, highly selective targeted therapies to halt key tumor escape mechanisms and prolong response to treatment.
About GSK
GSK is a global biopharmaceutical company that aims to unite science, technology and talent to advance the fight against diseases together. Find out more at gsk.com.
Cautionary statement regarding forward-looking statements
GSK cautions investors that any forward-looking statements or forecasts made by GSK, including those contained in this announcement, are subject to risks and uncertainties that could cause actual results to differ materially from those projected. These factors include, but are not limited to, those described under Item 3.d. Risk Factors in GlaxoSmithKline's 2023 Annual Report on Form 20-F and GSK's 2024 Third Quarter Results.
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References
1Bauer S, George S, von Mehren M, Heinrich MC. Early and next generation KIT/PDGFRA kinase inhibitors are the future of treatment for advanced gastrointestinal sarcomas. Front oncol. 2021 Jul 12;11:672500.
2 Zhou S, Abdihamid O, Tan F, Zhou H, Liu H, Li Z, Xiao S, Li B. KIT mutations and expression: current knowledge and new insights to overcome IM resistance in GIST. Common cell signal. 2024 Feb 27;22(1):153.
3George et al. CTOS 2024
4 George et al. CTOS 2024
5 Søreide K, Sandvik OM, Søreide JA, Giljaca V, Jureckova A, Bulusu VR. The global epidemiology of gastrointestinal sarcomas (GIST): a systematic review of population-based cohort studies. Cancer epidemiology. 2016 Feb;40:39-46.
6Bauer S, George S, von Mehren M, Heinrich MC. Early and next generation KIT/PDGFRA kinase inhibitors are the future of treatment for advanced gastrointestinal sarcomas. Front oncol. 2021 Jul 12;11:672500.
7 Zhou S, Abdihamid O, Tan F, Zhou H, Liu H, Li Z, Xiao S, Li B. KIT mutations and expression: current knowledge and new insights to overcome IM resistance in GIST. Common cell signal. 2024 Feb 27;22(1):153.
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Source: GSK plc and IDRx, Inc.
